Staged Diabetes Management

By Roger Mazze, Richard M. Bergenstal, Robert Cuddihy and 5 more

This new edition of the successful Staged Diabetes Management will again address the prominent issues of primary care diabetes management based on the International Diabetes Center’s "Staged Diabetes Management" program, which it advocates as part of its mission statement. This systematic treatment program consists of practical solutions to the detection and treatment of diabetes, its complications, and such areas as metabolic syndrome, pre-diabetes and diabetes in children using evidence-based medicine. The text reviews the fundamental basis of diabetes management and then addresses treatment of each type of diabetes and the major micro- and macrovascular complications.

• Language: English
• Publisher: Wiley
• Release date: Oct 14, 2011
• ISBN: 9781119950400

Book preview

Part 1: Diabetes care from the perspective of Staged Diabetes Management

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Introduction to Staged Diabetes Management

Key points

Integrated models of healthcare delivery address (1) organization and policy, (2) innovation and implementation, (3) measurement and outcomes, and (4) incentives and payment.

Effective changes in healthcare delivery respond to healthcare needs, the epidemiology of disease, and health policy.

Healthcare outcomes data often determine which healthcare changes materialize. Such outcomes data include morbidity and mortality measures and cost–benefit analyses.

Staged Diabetes Management is a systematic approach to clinical decision-making that applies the above principles for effective healthcare delivery. It applies an evidence-based medical model, is customized to reflect the healthcare environment, and is refined through outcomes measurement.

Where does Staged Diabetes Management (SDM) fit in the integrated model of change? At its inception, SDM was singular in purpose: to develop, implement, test, and refine an approach to diabetes care and its comorbidities that improved clinical outcomes. For more than two decades, SDM has remained focused on this purpose. Through ongoing development, translation of its clinical pathways into practice, and measurement of outcomes in medical practices, SDM has expanded its scope to encompass the complete natural history of diabetes, including the period before its inception. Complications management has been integrated as evidence amasses that links overall outcome to management of comorbid states. Associated conditions, such as eating disorders, are now included.

Developing Staged Diabetes Management

At the foundation of SDM is the principle that the approach itself cannot succeed if it is isolated as an innovation without addressing the other elements that constitute the integrated model. Understanding the history of SDM is fundamental to understanding its approach and underlying principles.

SDM was developed during an era of change and discovery. By the late 1980s, it was clear that the changes in diabetes care—focus on tight glycemic control, concern for prevention of complications, intensive education, nutrition management, and patient self-care—required a reevaluation of current care practices. While these issues were initially raised in Europe, the USA and Japan, they soon became universal. Most prominent was a change in the recognition as to who would manage diabetes. Between 1975 and 1985, the care of most people with diabetes in developed countries (e.g., Australia, New Zealand, France, the UK, Austria, Sweden, Norway, Finland, Belgium, Switzerland, Italy, Germany, Japan, the USA, and Canada) was believed to be within the purview of diabetes specialists. In most of these countries, a diabetes specialist or diabetologist was defined as an individual whose medical and postgraduate training was supplemented by an additional 2–3 years of researching and caring primarily for people with diabetes. In some countries, most notably Japan, the idea that a generalist in medicine would care for a person with diabetes was anathema. There and elsewhere, primary care management of diabetes was to be avoided, even at the cost of providing no medical care.

By the late 1980s, however, it was becoming apparent that the increased incidence and prevalence in type 2 diabetes required a reevaluation of the specialists-only approach to the care of adults with diabetes. During this time, diabetes care was split between those who were considered experts or specialists and those who were generalists. The latter were further segmented into the primary care specialties: family practice, pediatrics, obstetrics, and internal medicine. The specialties in diabetes were subsumed into endocrinology, perinatology and diabetology (the last a term used generally in developing countries for a specialist in diabetes). With specialists congregating in large metropolitan areas and the primary care clinicians scattered in rural areas, the two groups rarely met or shared their approaches to diabetes. This complex structure posed a seemingly insurmountable challenge: How would the research findings and related skills that were readily available to specialists find their way to primary care clinicians?

A second more pressing problem was how individuals with complicated diabetes in rural areas would access high-quality care. Through the late 1980s, this challenge was addressed either by having patients travel to the large medical centers in metropolitan areas or by having them do without these services. The individual with gestational diabetes at risk for cesarean section (C-section) either would move to the large medical center as early as 4 weeks before delivery or would rely on the local family physician, whose C-section experience was very limited. Although epidemiological studies were not geared toward answering the question of how to provide better access to diabetes care in remote areas, many believed that this period was characterized by a disproportionate number of episodes of diabetic ketoacidosis, amputation, neonatal mortality and perinatal morbidity when rural and urban centers were compared.¹

In the USA, the rising awareness of the need to rely on primary care clinicians to manage diabetes was most apparent in the rural states that constitute the heartland of America. There, reliance on family physicians, many of whom served as internist, pediatrician and obstetrician, obviated the case for diabetes. No other chronic disorder affected each stage of life. The question was simple: Can new research findings and approaches to diabetes be translated into primary care clinical practices? The same question was being asked in the UK public health service, the French and German national health programs, and countless developed and developing countries’ ministries of health.

SDM was created as a direct response to the needs of our constituencies at the International Diabetes Center (IDC) in Minneapolis, MN, USA. Because the IDC is recognized by the World Health Organization (WHO) as an expert center in the translation of research findings into clinical practice, the dilemma facing many countries became an IDC mission: to develop a model approach to diabetes that would rapidly translate diabetes research into practices that would allow the primary care clinician to provide exceptional care—equivalent to that of the specialist.

A model approach developed at the IDC would need to be applicable and tested in diverse clinical settings within the USA as well as in developed and developing countries attempting to alter diabetes care. The fundamental challenge was to convert diabetes management from an individualistic-based approach to one that was easily adapted to caring for large numbers of patients in environments with frequently suboptimal resources.

The Foundational Principles of SDM

From its inception, SDM was based on three underlying principles:

reproducible scientific evidence would guide clinical decisions

explicit clinical pathways would be formulated in such a manner as to identify the criteria for selection and advancement of therapy

all decisions would be tested against clinical outcomes.

Reproducible Scientific Evidence

Reproducibility of scientific evidence meant that (1) each element of the clinical pathways (DecisionPaths) would have to be tested, (2) the overall approach would need to reflect the natural history of diabetes, (3) the DecisionPaths would be subject to constant review, revision, and retesting, and (4) the reliance on quantitative data would take precedence over qualitative clinical impressions.

Explicit Clinical Pathways

Explicit clinical pathways resulted in the production of Master and Specific DecisionPaths for each type of diabetes, each treatment modality, and each major step (starting, adjusting, and maintaining) in the treatment pathway (Figure 1.1).

Figure 1.1 Type 2 Master DecisionPath. A1c, hemoglobin A1c; CV, cardiovascular; DPP-4, dipeptidyl peptidase-4; FPG, fasting plasma glucose; GI, gastrointestinal; GLP-1, glucagon-like peptide 1; RPG, random plasma glucose; SMBG, self-monitored blood glucose; SU, sulfonylurea; TZD, thiazolidinedione.

© 2011 International Diabetes Center at Park Nicollet. All rights reserved and protected.

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Testing Decisions Against Clinical Outcomes

The idea that all decisions would be subjected to verification in clinical outcomes was perhaps the most challenging. SDM would, by design, require incorporation of sentinel process and outcome measures, which by their nature require consensus. Sentinel outcome measures vary by clinic, medical center, national diabetes organization, and government health ministries.

More than a decade ago, the American Diabetes Association (ADA), in collaboration with the National Committee on Quality Assurance (NCQA), identified key or sentinel measures for type 1 and type 2 diabetes. Their selection was based on a consensus from experts and therefore should be considered a guide rather than a standard. Among the measures were both processes (e.g., percentage of patients with at least one measurement of hemoglobin A1c (HbA1c)) and outcomes (e.g., HbA1c level). Also included were measures related to macrovascular disease (hypertension and dyslipidemia), microvascular disease (retinal examination and renal status), and education and nutrition. It was believed that these sentinel events reflected the quality of care provided by the institution.

The ADA and NCQA formalized the program of evaluation of sentinel events, officially calling it the Diabetes Physician Recognition Program (DPRP). The IDC uses these sentinel measures to assess SDM effectiveness in its national and international SDM implementation programs.

Thus, SDM is a systematic approach to the prevention, detection, and treatment of diabetes and metabolic syndrome and their complications. At the foundation of SDM lie three principles:

1 identify the underlying physiological defect

2 match the therapy to the underlying defect

3 if one therapy fails, find an alternative; continue advancement of therapy until the outcome is achieved or maintained.

Stages of Staged Diabetes Management Therapy

SDM organizes care in terms of stages and phases. Stages refer to type of treatment, with the underlying concept that there should be a consistency in the use of treatment modalities. For example, the notion that medical nutrition and activity therapy (MNT) is composed of both diet planning and activity is a critical element in the management of both blood glucose and blood pressure. Thinking in terms of stages adds a dynamic component; treatment is subject to initiation, adjustment, maintenance, and at times cessation. It places diabetes care in a continuum, beginning with diagnosis and/or initiation of a therapy (starting phase) and moving to the adjusting phase until the targets are reached, at which point the current therapy is maintained.

Advances in diabetes therapies, like the disease itself, are dynamic. In the past decade, a new classification of pharmacological agents, incretin-based therapies has been introduced, and older classifications, such as sulfonylureas and insulin, have been reexamined. To promote the dynamic nature of SDM, we chose to call each therapy a stage. The stages include MNT alone or in combination with pharmacological agents, oral hypoglycemic and secretory agents, incretin-based therapies and insulin therapy.

Medical Nutrition and Activity Therapy

In all types of diabetes, MNT combines carbohydrate distribution and caloric intake with activity expenditure. The SDM approach to MNT is to optimize the roles of nutrition and physical activities in lowering blood glucose levels as solo treatment, or to use them in combination with pharmacological agents. A secondary function of this therapy is to achieve and maintain desirable body weight.

Insulin Sensitizers, Secretagogues, and Potentiators

These agents are in two general categories based on their action: hypoglycemic or nonhypoglycemic. However, these classifications may be misleading. The oral and noninsulin injectable medications are better understood based on their mode of action:

Hypoglycemic agents (e.g., sulfonylureas) stimulate insulin production and secretion without regard to the level of glycemic control. Essentially, they are not controlled by ambient glucose.

Nonhypoglycemic agents are either modulated by the level of glycemic control (e.g., incretin-based therapies) or indirectly affect insulin’s effect. For example, they include biguanides as well as glucagon-like peptide 1 receptor agonists and dipeptidyl peptidase-4 inhibitors.

Insulin-based Therapies

Generally categorized by their action curve and duration, insulin-based therapies include:

rapid acting (15 minutes to 3–5 hours)

regular (30 minutes to 8 hours)

intermediate acting (14–24 hours)

long acting (up to 24 hours).

Phases of Staged Diabetes Management Therapy

Approaching the treatment of any disease without a structure in mind is akin to driving with a final destination in mind but without a map to follow. To make certain that we have a map and that we know where we are on it, SDM divides the stages into three phases: start, adjust, and maintain. These phases reflect the dynamic nature of treatment. At any time in treatment, the individual is in one of these three phases. Knowing the phase is analogous to knowing one’s place on the map. It is possible to understand instantaneously the progress of treatment as well as its goal.

Start Phase

The start treatment phase refers to the collection of data upon which to base diagnosis and initiate treatment. Ideally, diabetes care and management of complications begin with baseline data from which the practitioner can assess a patient’s clinical status. Each type of diabetes, associated complication, or comorbidity requires different data for diagnosis and clinical decision-making. In type 1 diabetes, for example, clinical symptoms, blood glucose level, antibodies to insulin, insulin level, urine or serum (blood) ketones, serum pH, age, and body weight serve as critical starting points. In type 2 diabetes, blood glucose values, HbA1c level, body mass index, insulin level, comorbidities, age, and sex are critical elements in understanding the nature of this disease. In the latter instance, understanding the underlying metabolic defect—insulin resistance, relative or absolute insulin deficiency, or incretin dysfunction—is vital for therapy selection.

Adjust Phase

During the adjust treatment phase, changes in therapy—whether in dose, timing/regimen, food plan, or exercise/activity—are made to optimize metabolic control. Lasting anywhere from days to months, this phase is marked by substantial patient involvement in collecting data upon which clinical decisions depend. The principles and data by which major alterations in treatment are made are mapped out in the Master DecisionPaths and Specific DecisionPaths for each stage. Detailed in the start and adjust DecisionPaths for each stage (therapy) of diabetes management are the selection criteria, initial dose calculations, and contraindications. For the purpose of routine diabetes management, a single standard or guideline for glucose control is highly desirable. Several multicenter clinical trials have concluded that, independent of the type of diabetes, the purpose of treatment is to safely restore near-normal glycemic patterns. The exact nature of near normal remains controversial. SDM defines near normal as safely mimicking diurnal glucose patterns of individuals without diabetes. While the results of the Diabetes Control and Complications Trial² in type 1 diabetes, the UK Diabetes Prospective Study,³ and the Action to Control Cardiovascular Risks in Type 2 Diabetes (ACCORD trial)⁴ generally demonstrated the desirability of one standard of glucose control, it should be understood that the glycemic goals tend to be in the form of acceptable ranges—for example, 70 and 140 mg/dL (3.9 and 7.8 mmol/L) for nonpregnancy and 60–120 mg/dL (3.3–6.7 mmol/L) in pregnancy. These ranges tend to be based on consensus rather than on randomized controlled trials comparing all potential ranges. Increasingly, studies are relying on glycosylated hemoglobin as their clinical definition of normal. Such studies target HbA1c below 7%, 6.5%, or 6% (normal is generally considered <5.7% in nonpregnancy).

SDM employs the following principle: if the metabolic goal is not met within a specified period of time, the therapy should be adjusted, supplemented, or replaced. It is this last point that underscores the need for thinking about diabetes in terms of phases. The goal should be to move the patient from adjust to maintain as quickly and as safely as is reasonable. Patients in the adjust phase are at higher risk for complications. It is not until they reach the maintain phase that the risk of complications is substantially lowered.

Maintain Phase

This phase begins when the patient has reached and is involved in maintaining the diurnal glucose patterns associated with the long-term prevention of complications. Patients are expected to move in and out of this phase independent of the type of treatment, based on such factors as changes in lifestyle, compliance with regimen, psychological and social adjustment to diabetes, willingness to achieve tighter control, and natural progression of diabetes. Thus, some changes in therapy are expected in this phase, but they are related more to fine-tuning than to major alterations in dose of medication.

Phases in the Treatment of Insulin Resistance and Complications

As with the treatment of diabetes, management of insulin resistance-related disorders such as prediabetes, dyslipidemia, and hypertension can be organized into start, adjust, and maintain therapy. Naturally, for each disorder, the object is to restore normal or near-normal status whenever possible. In many cases, because of preexisting comorbidities, the objective is to prevent further progression of the complication.

Principles for Practice Guidelines

SDM relies on local, national, and international standards to lay the foundation for treatment. SDM consists of a set of practice guidelines for each type of diabetes, for metabolic syndrome, and other complications. Practice guidelines are structured to address prevention, screening, and diagnosis; treatment options; metabolic targets; monitoring; and follow-up. Table 1.1 shows the type 2 diabetes practice guidelines. These guidelines are for adults and may not apply to pediatric patients.

Table 1.1 Type 2 diabetes practice guidelines (based on US practice)

A1c, hemoglobin A1c; BMI, body mass index; BP, blood pressure; CGM, continuous glucose monitoring; CVD, cardiovascular disease; ESRD, end-stage renal disease; FPG, fasting plasma glucose; GLP-1, glucagon-like peptide 1; HDL, high-density lipoprotein; IFG, impaired fasting glucose; IGT, impaired glucose tolerance; LDL, low-density lipoprotein; MNT, medical nutrition and activity therapy; OGTT, oral glucose tolerance test; SMBG, self-monitored blood glucose; TRI, triglycerides; UTI, urinary tract infection.

For more than a decade, the US Institute of Medicine (IOM) has been evaluating the characteristics of practice guidelines that contribute to successful implementation. Defined by the IOM, practice guidelines are systematically developed statements to assist practitioner and patient in decisions about appropriate healthcare for specific clinical circumstances.⁵ Incorporating science and clinical judgment, practice guidelines are meant to improve the quality of care by ensuring consistency in the delivery of healthcare services. Quality of care has been directly associated with reduced variation in medical practice.⁵ A common practice guideline accepted by all healthcare providers removes inconsistencies in the diagnosis and treatment of medical conditions and results in more effective use of healthcare resources, improved outcomes, cost savings, and reduced risk of legal liability for negligent care.

In its guidelines for clinical practice, the IOM argues that …scientific evidence and clinical judgment can be systematically combined to produce clinically valid, operational recommendations for appropriate care that can and will be used to persuade clinicians, patients and others to change their practices in ways that lead to better health outcomes and lower healthcare costs.⁵ Valid practice guidelines facilitate consistent, effective, and efficient medical care and ultimately lead to improved outcomes for patients. To accomplish this goal, guidelines must contain sufficient detail to have measurable clinical outcomes. For best results, practice guidelines should be specific, comprehensive, and accepted by the community of physicians and other medical team members. Guidelines need to be flexible enough for everyday use in clinical practice and must reflect the available community resources.

The first principle of practice guidelines is that they are based on sound scientific findings. SDM practice guidelines are based on the recommendations of the ADA, the National Diabetes Data Group, the International Diabetes Federation, the WHO, the American Association of Diabetes Educators, the American Association of Clinical Endocrinologists, and other diabetes organizations representing several countries outside the USA. These organizations have reviewed the current scientific data and many have reached consensus on major elements of diabetes care:

diagnostic criteria and classification

treatment options

therapeutic targets for blood glucose, HbA1c, blood pressure, and lipids

frequency of blood glucose, urine ketones, and HbA1c monitoring

complication surveillance (eye and foot examinations, screening for microalbuminuria)

medical follow-up

need for intensive treatment of complications.

These organizations have also addressed insulin resistance and many have reached a working consensus that does the following:

relates insulin resistance to hyperglycemia, hypertension, dyslipidemia, central obesity, and renal disease

recognizes the need to intensively screen, diagnose, and treat each condition

recognizes the increased risk of developing one condition when another exists

sets general treat outcome goals.

The second principle of practice guidelines is that they contain sufficient specificity to allow for their implementation. The SDM Master and Specific DecisionPaths (Figures 1.2 and 1.3) aid in implementing the practice guidelines.

Figure 1.2 Type 1 Master DecisionPath. FPG, fasting plasma glucose; RPG, random plasma glucose; MNT, medical nutrition and activity therapy.

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Figure 1.3 Type 2 metformin/start. CHF, congestive heart failure; A1c, hemoglobin A1c.

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The third principle of practice guidelines is that they are adapted to the community, adopted by the healthcare providers, and reflect the specific resources of the community. The key components of this process include the following:

community needs assessment and engagement

orientation to SDM

adaptation and adoption of practice guidelines by healthcare professionals

implementation plan for SDM

plan for short-term and long-term outcome assessment.

Master DecisionPath

The SDM Master DecisionPath (Figure 1.2) outlines the therapeutic stages for each type of diabetes and shows the most effective route for attaining glycemic control. The Master DecisionPath also provides a generalized method for initiating and altering treatment. Based principally upon blood glucose levels—measured by fasting and/or casual venous and capillary methods, and HbA1c—the selection of therapies has become more complicated as experts gain greater understanding about additional biomarkers (such as insulin level), symptoms, and physiological conditions. By laying out the therapies according to specific criteria, the selection process can become more consistent. Employing a common DecisionPath enables all team members and the patient to understand the overall treatment plan. It also enables the team to understand the alternative treatments should the initial selection fail. Finally, it establishes a treatment timeline. If a therapy fails, the Master DecisionPath guides the progression to other stages.

Specific DecisionPaths

The heart of the DecisionPath approach is the intersection of stage and phase (start, adjust, or maintain). SDM provides a Specific DecisionPath for each such intersection, which describes the action to be taken in terms of the specific therapy and also indicates the general path being followed and the progress being made. There are two types of Specific DecisionPath: start and adjust/maintain.

Using type 2 diabetes metformin/start as an example (Figure 1.3), note that the structure of the start DecisionPath begins with the entry criteria (blood glucose at diagnosis or failure of a previous therapy). It then moves to the medical visit and the blood glucose targets along with notes related to starting the treatment. After the how to start comes the follow-up information. The same structure is used for all start DecisionPaths.

A second type of Specific DecisionPath relates to adjusting/maintaining the current therapy. As shown in the metformin/adjust DecisionPath (Figure 1.4) the DecisionPath begins with a brief review of key data and a reminder of the target levels. These data (current medications, diabetes control, adherence, weight change, and hypo/hyperglycemic events) are common for all forms of diabetes. This review is followed by a closer evaluation of current glycemic control.

Figure 1.4 Type 2 metformin/adjust. A1c, hemoglobin A1c; BG, blood glucose.

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When glycemic target levels are reached, the patient enters a maintenance phase. The DecisionPaths for adjusting therapy contain guidelines for routine follow-up, which are consistent with the standards of practice recommended by national diabetes organizations. These include the frequency of visits and the period of time between visits. Over the period of 1 month, the average self-monitored blood glucose should drop by 15–30 mg/dL (0.8–1.7 mmol/L), which corresponds to a drop in the HbA1c of 0.5–1 percentage point. If this is occurring, the current treatment is continued without any adjustment. If these criteria are not met, further adjustment is necessary.

If the target blood glucose level has not been reached, the next step is to determine why. Often, the therapy does not match the underlying defect. Sometimes, however, patient nonadherence to the regimen is the cause. When this is the case, the Ancillary DecisionPaths entitled Psychological and Social Assessment and Diabetes Management Adherence Assessment are used to address issues related to adherence. However, an underlying principle of SDM is that therapies, not patients, fail. Thus, if adherence is not the problem, the next step is to assess whether any improvement has occurred.

Each pharmacological agent has a maximum safe and effective dose. For oral agents, SDM utilizes maximum dose criteria provided in the package insert but also reports the clinically effective dose, which sometimes is well below the maximum recommended dose. For example, the clinically effective dose of sulfonylureas is approximately two-thirds the maximum dose. For insulin, in general, between 1 and 1.5 U/kg (depending on the type of diabetes and the age of the patient) is considered the maximum safe dose. Exceeding this range requires a reevaluation of the therapy.

SDM provides similar criteria for each adjust phase and provides reasons for moving from one stage to the next. For example, the choice of combination or insulin therapy is based on whether the lack of improvement is due primarily to fasting hyperglycemia or postprandial hyperglycemia. For background (basal) insulin, the criteria for moving to background (basal) and mealtime (bolus) insulin are persistent fasting hyperglycemia, nocturnal hypoglycemia, or insufficient improvement in HbA1c.

Criteria for Adjusting and Changing Therapy

The underlying principle in SDM is that there is a rational and consistent set of criteria that can be applied when considering moving a patient from one therapy (stage) to another. Part of the principle is that the decision is founded on (but not limited to) verified self-monitored glucose data and HbA1c. The therapeutic goal is to achieve a lowering of 0.5–1.0% in HbA1c each month with a parallel improvement in blood glucose as measured by an average 15–30 mg/dL (0.8–1.7 mmol/L) reduction in self-monitored blood glucose (SMBG) or continuous glucose monitoring (CGM) without an increased risk of hypoglycemia. To achieve this therapeutic goal, current therapy must be reconsidered frequently. Assessing the patient’s adherence to the treatment plan includes reviewing his or her blood glucose monitoring technique and records, reviewing his or her food plan and activity record, and assessing the patient’s consistency in following the pharmacological regimen.

An important step in assessing the current therapy is to ensure that a sufficient number of self-monitored tests are performed and that the data from these tests are verified. Generally, when episodic testing is employed (SMBG), the optimal frequency is a minimum of four tests each day at randomly selected times. If CGM is employed, it is optimal to have at least 2 weeks of monitoring in order to understand the underlying diurnal pattern and select appropriate therapy. Thereafter, at least the same period (2 weeks) is required for therapy adjustment. The initial CGM can be supplemented by SMBG thereafter until a therapy change is indicated. If patterns of SMBG data confirm blood glucose levels consistently greater than target, CGM can be instituted to corroborate the SMBG and the therapy may be altered until the maximum effective dose is reached. If no improvement occurs, an alternative therapy is selected in accordance with the Master DecisionPath. The change to more complex therapies permits greater flexibility in reaching a particular blood glucose target.

Metabolic Syndrome, Complications, and Hospitalization DecisionPaths

The DecisionPaths for vascular complications, nephropathy, retinopathy, neuropathy, and foot disease generally follow the same format as those for treatment of diabetes. They differ in terms of their subject matter. They address prevention, screening, and diagnosis as well as starting and adjusting therapy (an example is provided in Figure 1.5).

Figure 1.5 Foot assessment and treatment. A1c, hemoglobin A1c.

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The Patient and Staged Diabetes Management

In principle, because patient participation is a fundamental part of SDM, providers should give a modified version of the Master DecisionPath to each patient to familiarize them with available therapeutic options. Along with learning about the Master DecisionPath, the patient should be aware of the tests that are generally performed, such as HbA1c. One approach is to provide patients with booklets or logbooks that provide places to record blood glucose and HbA1c targets and actual values. Electronic recordkeeping is also available, with software for downloading meters, pumps, and applications to follow trends. Additionally, SDM encourages the use of a progress record, a tool that allows patients and providers to track the course of treatment over time. The progress record provides the history of care at a glance, allowing both patient and provider to see where they have been and where they are going. This is a valuable aid in teaching and in maintaining adherence to complex therapies because the patient is kept informed and involved at every step.

The Diabetes Care Team and Team Development

Although the concept of a diabetes care team is not new, the idea that the patient is a member of the team remains controversial. Because of the reliance on patient-collected data combined with the need for the patient to cooperate, understand the therapies, and follow complex regimens, the patient must be considered at the center of the care team. In primary care management, the team may include the physician, nurse educator, nurse practitioner, physician’s assistant, pharmacist, and dietitian with the psychologist/social worker or exercise physiologist included where available. This team approach is especially needed in the absence of a diabetes specialist. If a specialist is available, the team might include both the primary care physician and a diabetes specialist. Under such circumstances, the DecisionPath to be followed would include the conditions for referral and would be shared by all involved in diabetes care.

DecisionPaths specify the role of each professional. The nurse and dietitian have especially unique roles to play, roles that in many instances the physician cannot assume without additional training and time. The DecisionPaths and the narratives include specific information about nutritional interventions and education.

Primary Care Provider

The primary care provider is specifically trained for, and skilled in, comprehensive first contact and continuing care for persons with diabetes, particularly adults. Responsibilities include health promotion, disease prevention, health maintenance, counseling, patient education, diagnosis, and treatment. The primary care provider coordinates the care of the individual with diabetes using other health professionals, consultation, and/or referrals as appropriate. The primary care provider serves as an advocate in the healthcare system for the patient so that cost-effective care can be achieved.

Frequently, primary care physicians would be considered the diabetologist, but this term itself is often misunderstood. In the USA, there is no such degree or board examination for the specialty of diabetology. A diabetologist is often considered any health professional with expertise in diabetes. However, for both legal and ethical considerations, the physician specialist in diabetes is generally referred to as a board-certified endocrinologist. This designation is different from those physicians whose practice concentrates on diabetes. Currently, the NCQA recognizes individual providers or groups of providers as a Recognized Physician, indicating that the physician (or group of physicians) has undergone a careful evaluation of clinical practice and met specific criteria for the treatment of diabetes. This focus on assessing expertise by clinical outcomes in place of formal education is in part recognition that extensive clinical experience with beneficial outcomes is an important factor in measuring clinical ability.

Diabetes Educator

The team member known as the diabetes educator provides initial and ongoing education related to self-management, survival skills, prevention and detection of complications, as well as diabetes skills training. Generally nurses, dietitians, pharmacists, and psychologists are educators who have extensive knowledge of diabetes medical management and ample experience in self-management education. In the USA, the National Certification Board for Diabetes Educators certifies the expertise of educators by making certain that they have provided at least 1000 hours of diabetes patient education and passed a national examination. Upon successful completion of the national examination, the healthcare professional is qualified as a Certified Diabetes Educator (CDE).

Registered Dietitian

The registered dietitian is responsible for assessing the nutritional needs of the individual and helping develop a food plan consistent with the nutrient requirements for growth and development in children and sustained good health in adults. Often a CDE as well, the dietitian addresses eating habits, suggests changes in behavior, and designs a course of action to optimize the nutritional component of diabetes care. Dietitians will also work with patients to establish an activity and/or exercise plan.

Psychologist/Social Worker

The psychologist/social worker assesses the individual’s initial and ongoing emotional adjustment to diabetes as well as the family’s adjustment. Recently, as patients are more involved in clinical decisions and day-to-day therapy adjustments, the psychologist’s role as a force for empowering patients to participate in their own care has received renewed emphasis.

Other Care Team Members

Pharmacists, podiatrists, exercise physiologists, and such specialists as cardiologists, neurologists, and nephrologists can also be members of the diabetes care team. The underlying concept of team care is that all healthcare providers and the patient agree in advance as to the course of treatment. This avoids both misunderstandings and counterproductive treatment. More important, it significantly reduces error.

Developing the Team

The idea that the team works closely together and is consequently in the same physical location has been replaced with the notion that the team comprises any group of healthcare professionals representing several disciplines with a common goal of improving care—specifically, restoring glycemic control to prevent microvascular and macrovascular complications. The advent of electronic-based medical records and self-care information has allowed for team development to be geographically and temporally separated. While ideally the team members should be located in the same facility and use electronic media to communicate in a coordinated fashion to assure that information is shared in a time-sensitive manner, proximity and systems compatibility is not always feasible. Large primary care multiclinic practices, for example, may require access to educators and dietitians but may not be in a position to locate these personnel in one center. For the convenience of both the patient and provider, they may have to be mobile. In a 4 year efficacy study of teams in diabetes management, the authors concluded that geographically separated teams require coordination and synchronization.⁶ Essentially, they argue that, for such teams to develop, they need to be synchronized and, although in different facilities, they must undergo the same key steps as would be undertaken in face-to-face team development.

Team development, whether in the same location or separated, is a four-step process: (1) forming, (2) storming, (3) norming, and (4) performing.⁷

1 Forming. In forming the team, members define the boundaries of their profession and detail their activities.

2 Storming. During the second, or storming, stage, conflicts over roles and responsibilities occur.

3 Norming. In the third stage, norming, team members resolve conflicts and establish routine interrelationships.

4 Performing. The fourth stage, performing, is measured by the ability of the team members to achieve their goals. This process requires agreement on care guidelines, goals, and clinical pathways, open access to the same data, patient participation, and, most important, ongoing assessment of team activities and clinical outcomes.

References

1 Mazze RS, Etzweiler DD, Strock ES, et al. Staged Diabetes Management: toward an integrated model of diabetes care. Diabetes Care 1994;17:56–66.

2 Diabetes Control and Complications Trial Research Group. The effect of intensive treatment of diabetes on the development and progression or long-term complications in insulin-dependent diabetes mellitus. New England Journal of Medicine 1993;329:977–86.

3 United Kingdom Prospective Diabetes Study Group. Effect of intensive blood-glucose control with metformin on complications in overweight patients with type 2 diabetes (UKPDS 34). Lancet 1998;352:854–65.

4 Action to Control Cardiovascular Risk in Diabetes Study Group, Gerstein HC, Miller ME, Byington RP, et al. Effects of intensive glucose lowering in type 2 diabetes. New England Journal of Medicine 2008;358:2545–59.

5 Field MJ and Lohr KN (eds). Clinical Practice Guidelines: Directions for a New Program. Institute of Medicine Publication 90-08. Washington, DC: National Academy Press, 1990.

6 Lapidos S, Rothschild S. Interdisciplinary management of chronic disease in primary practice. Managed Care Interface 2004;17:50–3.

7 Tuckman, B. Developmental sequence in small groups. Psychological Bulletin 1965;63:384–99.

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Implementation of Staged Diabetes Management

Key Points

Staged Diabetes Management is not limited to set of clinical pathways, practice guidelines, and team development; it is an active process promoting improved care through evidence-based medicine.

Staged Diabetes Management is a process for change, designed to optimize current resources to produce improved clinical outcomes.

Staged Diabetes Management requires a carefully and thoughtfully designed plan for implementation.

When Staged Diabetes Management (SDM) was initially developed, it was felt that its evidence-based approaches provided reason to follow its principles. Our theoretical foundation, however, suggested that a process to foster implementation was necessary. To fully implement SDM requires participation in the SDM process, which entails orienting to its principles, evaluating current practices, customizing elements of SDM for the community, identifying possible obstacles to implementation, conducting follow-up, and performing outcome assessment. This chapter describes this process in detail.

Note For readers currently participating in the SDM process, consider this text as part of the complete set of SDM materials, which also includes the Quick Guide. For those who are not currently participating in the SDM process, the material in this section provides a summary of all the program elements. Complete DecisionPaths are available in the updated Quick Guide. The Master DecisionPaths and practice guidelines will be the subject of building a consensus; through that process, the guidelines will be modified to reflect the unique resources of each community. Note that the examples provided in this chapter use data collected by healthcare organizations in the USA and around the world.

The goal of SDM is to ensure consistent, evidence-based prevention, detection, and treatment protocols for all types of diabetes and associated complications and syndromes. To achieve this goal, all providers and diabetes team members in the community need to become acquainted with, and follow, the same guidelines. A process based on consensus building is used to optimize the adoption of SDM.

Starting and maintaining a successful SDM program requires five steps:

1 community diabetes care needs assessment (includes a chart audit)

2 group formation

3 orientation to SDM

4 customization and implementation of SDM

5 evaluation of SDM.

Needs Assessment

SDM begins when a community understands that it needs to change how it approaches diabetes and associated diseases; in particular, how it intends to prevent, detect, and treat the disease and provide long-term care and education. Recognizing this may come as a result of a formal assessment of care and education practices, epidemiological data, or individual experience. SDM promotes a community-wide assessment of the current state of diabetes care (and may be expanded to include metabolic syndrome). This assessment provides the foundation for understanding the needs and demands of a community and its resources, and how these contribute to medical outcomes. The process also serves as the baseline against which changes in outcomes are measured. Measurements of epidemiological data, personnel, facilities, current level of metabolic control, and complications surveillance need to be obtained to complete an analysis of care processes in any community.

The areas to assess include the following.

Organizational information. Name of the organization, contact person, address, title, type of system (e.g., managed care organization), number and type of sites, number and type of healthcare providers, and chronic disease programs. This information is often already completed for in-house and public reporting. Check with the public information person at the facility (if such an individual exists).

Demographics. Age, sex, reimbursement mix (e.g., Medicare, managed care organization, fee for service, out-of-pocket), ethnicity, type of diabetes, and socioeconomic background must be collected. Community-wide demographics can be obtained from many sources, including state departments of health, ministries of health, and government agencies. Hospitals and clinics have periodic utilization review reports that contain this information.

Utilization data. Hospitalizations, average length of stay, referrals, inpatient services, and outpatient services. Hospital utilization review records are available to the public. Use these data to complete this section. Clinic data may be available by diagnosis for billing purposes.

Diabetes (and related) care services. Inpatient and outpatient care, education, number of full-time equivalents, resources (special facilities such as learning laboratories and nutrition centers), diabetes supplies, and support groups. This information is generally available from nurse educators, dietitians, and others who see large numbers of individuals with diabetes. If this is a recognized diabetes program, the annual report contains this information. NoteSince metabolic syndrome may include diabetes, it is unlikely that there are special services beyond a lipid, hypertension, and/or obesity clinic. Be sure to include these elements in the assessment.

Diabetes management. Current diagnostic criteria, standard measure of patient glucose control, complications surveillance, routine screening, and referral to specialists. It may be difficult to obtain this information in a local community and often multiple sources are required to obtain the information. Once it has been obtained, it can be used for an annual comparison to evaluate the diabetes management system. As information is collected, also ask the following questions about the diabetes care in the community:

Where is the diagnosis of diabetes made? In the physician’s office? In the hospital? In a screening clinic? In another facility? Is metabolic syndrome evaluated at the same time?

Who determines the initial therapy? Primary care physician? Specialist? Interdisciplinary team? Diabetes center?

Who educates the patient and family? Primary care physician? Nurse educator? Dietitian? Diabetes specialist? Interdisciplinary team? Public health nurse? Certified Diabetes Educator? Other?

Who is responsible for day-to-day management? Primary care physician? Nurse educator? Diabetes specialist? Interdisciplinary team? Public health nurse? Other?

Who manages complications? Primary care physician? Nurse educator? Diabetes specialist? Interdisciplinary team? Public health nurse? Other?

Who is responsible for nutritional assessment and follow-up? Dietitian? Primary care physician? Nurse educator? Diabetes specialist? Interdisciplinary team? Public health nurse? Other?

Who is responsible for scheduling annual complication surveillance examinations? Primary care physician? Nurse educator? Diabetes specialist? Interdisciplinary team? Public health nurse? Other?

Chart Audit

The chart audit has become the most common means of assessing care. Its goal is to improve the quality of disease management, and its objective is to measure quality by comparing collected data with an accepted standard. SDM uses the practice guidelines found in this text as the standard for the chart audit in order to assess the current level of diabetes care. The SDM practice guidelines, which are described in detail in each of the management chapters, consist of diagnostic criteria, treatment options, targets, monitoring, and medical follow-up timelines. These timelines are consistent with benchmarks established by such national and international organizations as the American Diabetes Association (ADA), the European Association for the Study of Diabetes, and the International Diabetes Federation.

A chart audit offers the following benefits:

insight into current management of diabetes and associated disorders in terms of identifying key factors that contribute to successful treatment outcomes

a real-world perspective

identification of variations in practice

a baseline measure

comparison with accepted benchmarks

quantification of current outcomes

documentation on use of existing guidelines.

The following are critical components of the chart audit:

obtaining permission

selecting charts

reviewing charts

summarizing results

conducting interviews

writing report.

Obtaining Permission

It is best to obtain a signed authorization to review charts. The person who authorizes the process may be a physician or director of medical records. The authorization should include the following information: the person(s) doing the review, the person(s) requesting the review, the purpose of the review, and how the data will be used. Be sure to state that the information will not be patient or physician specific. Some institutions require the patient to provide informed consent if the data will be used in future publications or public presentations.

The use of the chart audit is not internationally accepted. Many clinicians prefer that their patients’ records remain confidential. Under such circumstances, regional and national epidemiological data can be helpful. Small published studies and interviews with providers are also a means of assessing current care. The underlying purpose for this step in data collection is to provide a baseline from which changes can be measured. Many providers assume that changes will take place and therefore do not feel there is a need for baseline data.

Selecting Charts (Within the USA)

If possible, use medical records and quality improvement departments to select the charts for review randomly. At least 35 charts of patients with diabetes for each provider should be reviewed to meet National Committee on Quality Assurance (NCQA) recognition criteria. If more than six providers are working in the same facility, then 210 randomly selected charts meet the criteria for NCQA recognition. This provides a large enough sample from which to measure change in diabetes outcomes at a later date. If this is not the purpose, then the number of charts to be evaluated will vary depending on what kinds of change are being measured.

In large managed care organizations or clinics, chart audits for diabetes may have been completed already as part of quality improvement or certification; use these data if available. The underlying purpose is to demonstrate need and to provide a baseline against which changes may be measured (if that is necessary). It takes approximately 10–12 hours for a reviewer to audit 35 charts and another 2–4 hours to compile and summarize them. Whatever the method selected, make certain that it will meet the objective. Be careful to select charts in a random manner, such as every fourth or eighth chart for each provider. Be sure that the cases selected involve active patients. To avoid selecting the charts of deceased or inactive patients, randomly select only those patients seen at any time during the last year. Since these charts will be recalled after SDM is implemented, make certain that they are likely to remain in the community and to be seen over the next 6–12 months. Include patients in long-term care facilities or other institutional facilities.

Reviewing Charts

Use standard local audit forms or a national organization’s audit form for the specific type of diabetes, and fill out the information requested. Sometimes it is helpful to make additional notes in the margins of particular items to be remembered. Use the progress notes, laboratory data, additional correspondence, and any other flow sheet to collect the data. Review the written progress notes of the diagnosis of diabetes and then review the last 12 months of office visits, laboratory data, and additional healthcare services. In the following discussion, the SDM audit form is used.

For Collection of Demographic Data

Review the last 12 months of the clinic chart and note the visit date, chart number (no names), date of birth, sex, race/ethnicity, year of diabetes diagnosis, and weight. Sometimes it is difficult to find year of diagnosis information, so, if the chart has either a diagnosis or a medication summary in the front of the chart, use the dates there to find the date and confirm by looking at the clinic notes for that particular date. If a diagnosis or medication summary is not available, look in the laboratory section to find the first date of laboratory fasting blood glucose results greater than 126 mg/dL (7.0 mmol/L) or casual blood glucose 200 mg/dL (11.1 mmol/L) or higher—the diagnostic criteria for diabetes. If that cannot be found, read through the chart.

For Diabetes Outcome and Process Variable List

Review the last 12 months of the clinic chart. This section records hemoglobin A1c (HbA1c) data, annual eye and foot examinations, blood pressure, annual urine microalbuminuria screens, lipid profile, diabetes and nutrition education, whether or not the patient is self-monitoring blood glucose, self-monitored blood glucose (SMBG) target range, and whether or not the patient smokes. Many communities document target values via a letter to the patient when reporting the HbA1c results. Note whether the last HbA1c and average SMBG/continuous glucose monitoring (CGM) readings are within the targeted range. If a target range has not been identified and documented, the no box would be checked. List date and actual value of the last HbA1c and plasma glucose determinations as well as the frequency of HbA1c and laboratory plasma glucose obtained in the past year. Be sure to note the laboratory normal range and plasma glucose (because of differences in methodology, make certain to note whether plasma or whole blood analysis is used).

Check the specific complications or symptoms that have been documented by a healthcare provider. Note when laboratory values (such as lipids or presence of urine protein) or the physical examination findings (blood pressure) show the existence of complications but are not documented by the healthcare provider. Also review hospital record correspondence for the documentation of emergency room visits and hospitalizations for diabetic ketoacidosis, hyperglycemic hyperosmolar syndrome, or hypoglycemia. Note any eye examination (with dilation) that an ophthalmologist, optometrist, or primary care practitioner has performed within the past 12 months. Be sure to review both the progress notes and the correspondence section of the chart.

For Review of All Laboratory Data

There may also be a laboratory data flow sheet documenting dates and results. Also note how the chart documents SMBG. Are the SMBG data downloaded from a meter to a computer and the report placed in the chart? Is a copy of the patient’s record book included in the chart? Is there other documentation of the SMBG values in the chart? Include documentation of diabetes and nutrition topics covered by a nurse, dietitian, or physician. Note the amount of time the patient spends in any type of education related to diabetes. Many times, the actual education may be listed on a flow sheet within the chart or else in a separate chart, outside the clinic. Include the date of the last diabetes education. Be alert for patients who receive diabetes education upon diagnosis of diabetes or the initiation of a medication but receive no additional follow-up.

For Review of Diabetes Therapy

This covers the last 12 months of the clinic chart. Document the patient’s current therapy, whether it is medical nutrition and activity therapy (MNT) alone or in conjunction with oral agents and/or insulin. Check the type of oral medication or insulin the patient is on and record the current regimen based on the SDM model of AM–midday–PM–bedtime. If the patient has been on a particular therapy for a long period of time and has not reached the target goals, it is sometimes helpful to note the last date of the change in therapy. Many healthcare organizations are using electronic medical records. Some or all of the information for the chart audit may be available through the electronic medical record system being employed.

For Review of Metabolic Syndrome Therapy

Note whether insulin resistance or related comorbidities (hypertension, dyslipidemia, renal disease, obesity, polycystic ovary syndrome, or acanthosis nigricans) are recorded. Determine whether the patient is in treatment for hypertension, dyslipidemia, or any of the insulin resistance-related disorders. If the patient is on a special diet for obesity or renal disease note this as well.

Summarizing Results

Compile the data from multiple charts into a one-page tabulated summary. This will assist in reporting to the community the current management practices.

Conducting Interviews

Sometimes a chart audit misses critical points in treatment because they are not documented. It is important to determine to what extent the chart reflects actual care processes. Interview as many providers as possible to verify the chart audit findings (e.g., nurse, dietitian, physician). These findings should be included in the written report. The fact that they were uncovered only after interviews will already suggest the need for better documentation.

Writing Report

With the audit completed, most communities will want a written report of the chart audit. Use the completed forms along with additional information attained by the assessment described above to write a report for the community.

Group Formation

Forming a group is a very important step in initiating SDM. The focus is to identify health professionals, institutions, and organizations with a genuine interest in using community-customized practice guidelines to improve care and education processes. Community refers to individuals with a common interest in developing, implementing, and monitoring practice guidelines for diabetes and associated disorders. The community can be a managed care organization, a group practice, a primary care clinic, a medical center, a department within a medical school, or an entire region of networked physicians and other care providers. Communities can also include national organizations such as diabetes societies. The concept is the reaching of a consensus by all interested parties to assure the application of evidence-based practices.

To move SDM from being just a good idea to a working system in a community, stakeholders must commit resources for adopting a new and standardized method of care. These resources can be divided into four general components: personnel, equipment and supplies, physical facilities, and finances. These are generally known as throughputs. They serve to convert demands and needs as expressed by the people in the community into improved outcomes by providing services to people at risk for, and with, a disease. Central to organizing these throughputs is the champion: an individual or individuals who support change in their community and are willing to lead this effort. This champion will need coleaders or coordinators to help in contacting, educating, and supporting other community healthcare providers and other key staff. Coordinators are motivated, and willing to fully participate in a process that will take time and energy. Coordinators often are members of existing diabetes care and education teams and have a stake in seeing diabetes care improved in the community. Team members can include primary care physicians, diabetes nurse educators, registered dietitians, psychologists or social workers, and diabetes specialists. Although all of these types of professionals may not be available in the community, the areas of education,